Cardiac valve delivery devices and systems

ABSTRACT

A delivery device includes a central elongate structure including an annular member at the distal end, a sheath, a plurality of tethers extending through the central elongate structure, a handle, and a control on the handle. The handle is connected to the elongate structure, the sheath, and the plurality of tethers. The control is configured to move the sheath proximally and distally over the central elongate structure. The annular member includes a plurality of pockets extending radially therearound. Each tether includes a feature on a distal end thereof configured to fit within a pocket of the plurality of pockets to hold the tethers in place.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. application Ser.No. 15/573,555, filed on Nov. 13, 2017, which application is a nationalphase entry under 35 U.S.C. § 371 of International Application No.PCT/US2016/032546, filed on May 13, 2016, which claims the benefit ofthe filing date of U.S. Provisional Patent Application No. 62/161,747,filed May 14, 2015, titled “CARDIAC VALVE DELIVERY DEVICES AND SYSTEMS,”the disclosures of which are hereby incorporated by reference herein.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

The present invention relates generally to the treatment of cardiacvalve disorders, such as mitral valve replacement, using minimallyinvasive techniques. In particular, this application is directed towardsdevices for delivering and placing replacement mitral valves.

BACKGROUND

The mitral valve lies between the left atrium and the left ventricle ofthe heart. Various diseases can affect the function of the mitral valve,including degenerative mitral valve disease and mitral valve prolapse.These diseases can cause mitral stenosis, in which the valve fails toopen fully and thereby obstructs blood flow, and/or mitralinsufficiency, in which the mitral valve is incompetent and blood flowspassively in the wrong direction.

Many patients with heart disease, such as problems with the mitralvalve, are intolerant of the trauma associated with open-heart surgery.Age or advanced illness may have impaired the patient's ability torecover from the injury of an open-heart procedure. Additionally, thehigh costs associated with open-heart surgery and extra-corporealperfusion can make such procedures prohibitive.

Patients in need of cardiac valve repair or cardiac valve replacementcan be served by minimally invasive surgical techniques. In manyminimally invasive procedures, small devices are manipulated within thepatient's body under visualization from a live imaging source likeultrasound, fluoroscopy, or endoscopy. Minimally invasive cardiacprocedures are inherently less traumatic than open procedures and may beperformed without extra-corporeal perfusion, which carries a significantrisk of procedural complications.

Prosthetic valve replacement procedures can be difficult, and variousfactors are generally taken into account when placing the valve. First,the prosthetic valve should be placed at the same or very nearly thesame angle as the native valve. A valve that is off axis could causeturbulent blood flow and/or potential para-valvular leaks. Second, theprosthetic valve should ideally have concentricity. This means that thevalve is placed in the same center as the native valve. An off centerdeployment or valve placement could affect the mechanism of neighboringvalves or the heart's conductive system. Finally, the prosthetic valveshould be at the proper depth within the patient's heart with respect tothe location of the native valve, as otherwise, the prosthetic valve mayinterfere with the conductive nature of the heart as well.

A safe and efficient delivery system and method for replacement of acardiac valve that addresses some or all of these concerns is describedherein.

SUMMARY OF THE DISCLOSURE

In general, in one embodiment, a delivery device includes a centralelongate structure, a sheath configured to slide over the centralelongate structure, a plurality of tethers extending through the centralelongate structure, a handle, and a control on the handle configured tomove the sheath proximally and distally over the central elongatestructure. The central elongate structure includes an annular member ata distal end. The handle is connected to the elongate structure, thesheath, and the plurality of tethers. The annular member includes aplurality of pockets extending radially therearound. Each tetherincludes a feature on a distal end thereof configured to fit within apocket of the plurality of pockets to hold the tether in place.

This and other embodiments can include one or more of the followingfeatures. The feature can be a cone or a sphere. The feature can beradiopaque. The handle can further include a locking mechanismconfigured to prevent the control from moving the sheath past a setdistance, thereby preventing the features from releasing from thepockets. The locking mechanism can be releasable so as to allow thesheath to move past the set distance to release the features from thepockets. The handle can further include a tether controller configuredto provide tension or release tension to each of the plurality oftethers. The handle can further include a tether lock having an open andclosed position configured to prevent further loosening or tensioning ofthe tether when the tether lock is in the closed position. The handlecan further include a secondary release knob coupled to the tethercontroller for allowing the plurality of tethers to be released at theirproximal ends. The delivery device can further include a ratchetingassembly configured to prevent forward and back driving of the tethercontroller. The ratcheting assembly can include a plurality of ratchetscoupling the tether controller and the secondary release knob, two beadssymmetrically disposed in two channels within the secondary releaseknob, and three wells adjacent to the bottom of each of the two channelssuch that only one well is exposed to the bottom of each of the twochannels at any one time. The two beads can be maintained at the bottomof the two channels with corresponding springs, and tension to the twobeads may be released with corresponding actuators. A location of eachbead in one of the three wells of each channel can correspond tolimiting tether controller movement in one direction, limiting tethercontroller movement in an opposite direction, or allowing the tethercontroller to move in the first or the second direction. The deliverydevice can further include a series of magnetic strips along one side ofthe device. The delivery device can further include a grasper that isconfigured to magnetically couple to the delivery device through theseries of magnetic strips. The grasper can include a coupling apertureadapted to couple to a support arm and a grasper knob that when turnedis adapted to move the delivery device in an axial direction for placinga prosthetic valve. The delivery device can further include an outersheath configured to cover a distal portion of the delivery device formaintaining an incision site during a prosthetic valve placementprocedure. The outer sheath can further include an annular groove at itsdistal end for coupling to an incision site boundary when the incisionsite boundary is cinched together. The delivery can further include aprosthetic valve loading aid for placing the prosthetic valve into thesheath.

In general, in one embodiment, a method of delivering a prostheticmitral valve includes: (1) extending a prosthetic delivery device into aheart with the prosthetic mitral valve collapsed within a sheath of thedelivery device; (2) pulling the sheath proximally to expose at least adistal anchor of the prosthetic valve, thereby allowing the distalanchor to self-expand to an expanded annular configuration on a firstside of the mitral valve annulus; (3) pulling the valve proximally toseat the distal anchor in the expanded annular configuration against amitral valve annulus; (4) loosening a plurality of tethers of thedelivery device so as to allow the proximal anchor to self-expand to anexpanded annular configuration on a second side of the mitral valveannulus, the expansion of the proximal anchor causing the proximalanchor to move towards the distal anchor and capture tissue of themitral valve annulus between the proximal anchor and the distal anchor;(5) pulling the sheath further proximally to allow the tethers torelease from the proximal anchor; and (6) removing the delivery devicefrom the heart.

This and other embodiments can include one or more of the followingfeatures. The step of pulling the sheath further proximally can releasedistal ends of the tethers. The method can further include releasing aproximal end of at least one tether if a distal end of the at least onetether becomes tangled. Distal ends of the tethers can be configured tofit within pockets of the delivery device, and the step of pulling thesheath further proximally can release the distal ends of the tethers.The distal ends of the tethers can include enlarged features configuredto fit within the pockets. The enlarged features can be cones orspheres. The method can further include: (1) tightening the plurality oftethers to re-collapse the proximal anchor before the step of pullingthe sheath further proximally; (2) moving the distal anchor to a newposition against the mitral valve annulus; and (3) re-loosening theplurality of tethers so as to allow the proximal anchor to self-expandto an expanded annular configuration on a second side of the mitralvalve annulus, the expansion of the proximal anchor causing the proximalanchor to move towards the distal anchor and capture tissue of themitral valve annulus between the proximal anchor and the distal anchor.

In general, in one embodiment, a method of delivering a prostheticmitral valve includes: (1) extending a prosthetic delivery device into aheart with the prosthetic mitral valve collapsed within a sheath of thedelivery device; (2) sliding the sheath to expose at least a proximalanchor of the prosthetic valve and allowing the proximal anchor toself-expand to an expanded annular configuration on a first side of themitral valve annulus; (3) allowing a distal anchor of the prostheticvalve to self-expand on a second side of the mitral valve annulus afterallowing the proximal anchor to self-expand, the expansion of the distalanchor causing the distal anchor to move towards the proximal anchor andcapture tissue of the mitral valve annulus between the proximal anchorand the distal anchor; and (4) removing the delivery device from theheart.

This and other embodiments can include one or more of the followingfeatures. Sliding the sheath can include sliding the sheath distally.Sliding the sheath to expose at least a proximal anchor of theprosthetic valve can allow the proximal anchor to self-expand to anexpanded annular configuration. Allowing the distal anchor toself-expand can include loosening a plurality of tethers of the deliverydevice that are coupled to the distal anchor.

In general, in one embodiment, a method of delivering a prostheticmitral valve includes: (1) extending a prosthetic delivery device into aheart with the prosthetic mitral valve collapsed within a proximalsheath and a distal sheath of the delivery device, wherein the distalsheath is configured to telescope over a portion of the proximal sheath;(2) sliding the proximal sheath proximally to expose at least a proximalanchor of the prosthetic valve and allowing the proximal anchor toself-expand to an expanded annular configuration on a first side of themitral valve annulus; (3) allowing a distal anchor of the prostheticvalve to self-expand on a second side of the mitral valve annulus afterallowing the proximal anchor to self-expand by extending the distalsheath, the expansion of the distal anchor causing the distal anchor tomove towards the proximal anchor and capture tissue of the mitral valveannulus between the proximal anchor and the distal anchor; and (4)removing the delivery device from the heart.

This and other embodiments can include one or more of the followingfeatures. Sliding the proximal sheath to expose at least a proximalanchor of the prosthetic valve can allow the proximal anchor toself-expand to an expanded annular configuration after loosening aplurality of tethers of the delivery device that are coupled to theproximal anchor. Allowing the distal anchor of the prosthetic valve toself-expand can include sliding the distal sheath in a distal direction.The plurality of tethers can further be tensioned to completely free theplurality of tethers from the proximal anchor.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 shows an exemplary prosthetic valve delivery device.

FIG. 2A shows another embodiment of a prosthetic delivery device.

FIG. 2B is a cross-section of FIG. 2A.

FIG. 3 shows the delivery device of FIG. 2A with the sheath partiallyproximally withdrawn.

FIG. 4 shows the delivery device of FIG. 2A with the tethers exposed.

FIG. 5 shows the delivery device of FIG. 2A with the tethers partiallyretracted.

FIG. 6 shows the delivery device of FIG. 2A with the tethers andretaining elements fully released.

FIG. 7 shows another embodiment of a prosthetic valve delivery device.

FIG. 8 shows another embodiment of a prosthetic valve delivery device.

FIG. 9 shows another embodiment of a prosthetic valve delivery device.

FIG. 10 shows another embodiment of a prosthetic valve delivery device.

FIG. 11A shows another embodiment of a prosthetic valve delivery device.

FIG. 11B shows a close-up of the delivery device of FIG. 11A without anouter sleeve and a tether loading cone.

FIG. 11C shows a cross-section of the delivery device of FIG. 11A alongits longitudinal axis without a grasper.

FIG. 12A shows the delivery device of FIG. 11A unsheathed.

FIG. 12B shows a cross-sectional view of the unsheathed delivery deviceof FIG. 12A.

FIG. 12C shows a close up of the cross-section of the distal end of theunsheathed device of FIG. 12A.

FIG. 13A shows the fully unsheathed delivery device of FIG. 12A where atether control knob has been pushed distally along with a series ofhypotubes for deploying a proximal end of a replacement prostheticvalve.

FIG. 13B is a cross-sectional view of the fully unsheathed deliverydevice of FIG. 13A.

FIG. 13C shows a close up of the cross-section of the distal end of theunsheathed device of FIG. 13A where a series of hypotubes have advanceddistally.

FIG. 14 shows the delivery device of FIG. 11A where a clip maintainingtether tension has been removed.

FIG. 15A shows the delivery device of FIG. 11A where a tether endsholder near the distal end is exposed, and tether ends are able torelease.

FIG. 15B shows a close-up of the tether ends retainer of FIG. 15A.

FIG. 16A and FIG. 16B show a tether ends retainer from on top and angledside view.

FIG. 17 shows a cross-section of a tether control lever and a secondaryrelease knob.

FIG. 18A shows an alternative embodiment of the proximal tether controland retaining feature having a truncated conical washer.

FIG. 18B shows a top portion of the truncated conical washer of FIG. 18Ahaving three channels.

FIG. 19 shows a ratcheting system for maintaining the position of atether control lever and a secondary release knob.

FIG. 20A shows the delivery device of FIG. 11A having a prosthetic valveinserted onto the distal end but uncoupled to the delivery device.

FIG. 20B shows the delivery device of FIG. 11A having the prostheticvalve attached at its proximal end but not drawn into the deliverydevice.

FIG. 20C shows the delivery device of FIG. 11A having the prostheticvalve partially drawn into the delivery device.

FIG. 21A shows a top view of a grasper.

FIG. 21B shows a bottom view of the grasper of FIG. 21A.

FIG. 22 shows a side view of a handle of a delivery device for matingattachment to a grasper.

FIG. 23A shows another embodiment of a delivery device.

FIG. 23B shows a close up of the distal end of the delivery device ofFIG. 23A.

FIG. 23C shows the delivery device of FIG. 23A with a distal innersheath and a proximal inner sheath moving away from one another.

FIG. 23D shows the distal inner sheath and the proximal inner sheath ofFIG. 23C moving farther from one another.

FIG. 23E shows a tether retainer becoming exposed after the proximalinner sheath has been fully further in the proximal direction relativeto FIG. 23D.

FIG. 23F shows proximal ends of a prosthetic valve deployed but stillcoupled to a series of tethers of the delivery device of FIG. 23A.

FIG. 23G shows the prosthetic valve fully deployed and uncouple to thetether ends of the delivery device of FIG. 23A.

FIG. 24A shows another embodiment of a delivery device.

FIG. 24B shows a distal end inner sheath of the delivery device of FIG.24A partially extended in the distal direction.

FIG. 24C shows the distal inner sheath of the delivery device of FIG.24A extended in a position where proximal end petals are deployed.

FIG. 24D shows the distal inner sheathe extend at an even more distalposition relative to FIG. 24C such that an entire prosthetic valve hasbeen deployed.

FIG. 24E shows the distal inner sheath of FIG. 24A extended in thefarthest distal end position such that pockets of a tether retainer areexposed and allow the tether ends to be freed.

FIG. 24F shows the tether ends being retracted to allow the deliverydevice now to be removed.

DETAILED DESCRIPTION

The delivery devices described herein can be used to deliver and deploya wide variety of replacement heart valves, such as prosthetic valvesadapted to be minimally invasively delivered. Exemplary prostheticvalves that can be delivered and deployed include the expandableprosthetic valves described in application Ser. No. 14/677,320, filedApr. 2, 2015, in U.S. Pat. No. 8,870,948, and in International PatentApplication filed May 13, 2016, titled “REPLACEMENT MITRAL VALVES,” andin U.S. patent application Ser. No. 14/677,320, filed Apr. 2, 2015,titled “REPLACEMENT CARDIAC VALVES AND METHODS OF USE AND MANUFACTURE,”all of which are incorporated by reference herein. For example, thedelivery devices herein are configured to be able to delivery and deploya replacement heart valve, such as a mitral valve, with distal andproximal anchors.

Replacement heart valves can be collapsed into a delivery configurationso they can fit within the described delivery devices. The replacementheart valves can be delivered to the treatment site within the deliverydevice and then deployed from the delivery device. The delivery devicecan be configured such that the distal and proximal anchors can besequentially deployed as desired from a collapsed configuration to anexpanded configuration.

If necessary, the replacement valves can be repositioned, re-sheathed(partially or completely) if necessary, and then re-deployed.

In methods of use, the mitral valve prosthesis can be delivered usingone of the delivery devices described herein to a cardiac valve orifice,such as the mitral valve, by using minimally invasive techniques toaccess the cardiac valve. Access routes and procedures are known, suchas making small incisions in the patient's body and passing theprosthesis through the apex of the heart to, for example, a mitralvalve. This can be referred to as the transatrial delivery approach. Insuch a transatrial delivery system for a mitral valve replacement, thedistal-most anchor is delivered to the ventricle while the proximal-mostanchor is delivered to the atrium. An additional exemplary access routeincludes delivering the valve through the venous system and into theleft atrium via a transseptal puncture. A transseptal approach canimpart size limitations on the delivery and thus the delivery profile ofthe replacement heart valve. Additionally, a transseptal approach canalso impart certain flexibility requirements on the replacement heartvalve. For the transseptal delivery system for mitral valve replacement,the distal-most anchor is delivered to the atrium while theproximal-most anchor is delivered to the ventricle.

FIG. 1 illustrates an exemplary delivery device 100 that is configuredto deliver and deploy a mitral valve prosthesis. The delivery device 100allows self-expansion of a distal portion of the prosthesis, such as adistal anchor, and controlled deployment of a proximal portion of theprosthesis, such as a proximal anchor. The delivery device 100 includesa central control assembly that includes a central hub 107, which has alumen extending therethrough. Disposed within and secured within thelumen of the central hub 107 is central stem 118, which extends furtherdistally than the central hub 107, and whose distal region is coupled tonosecone 106. The central control assembly further includes a retainingmember 120 secured to the central stem 118 for controlling expansion ofthe valve prosthesis. Retaining member 120 is configured to interactwith a proximal region of the prosthesis (not shown for clarity) and,with the use of sheath 116 as described below, facilitate a controlleddeployment of the proximal region of the prosthesis.

Delivery device 100 further includes an outer sheath 116 coupled tosheath control 152. The central control assembly is disposed withinsheath 116, and the system is configured so that sheath 116 can beaxially moved (proximally and distally) relative to the central controlassembly. The distal region 123 of central hub 107, the proximal end ofnosecone 106, and the inner surface of sheath 116 define a prosthesisdelivery region 115, which is configured to receive and retain therein aprosthesis in a collapsed configuration for delivery.

While the prosthesis is not shown for clarity, in this configuration ofthe delivery device, the expandable prosthesis would be in a collapsedconfiguration inside delivery region 115 due to the radial constraintprovided by sheath 116. When collapsed, the proximal portion of theprosthesis interacts with, e.g. is attached to, raised elements 125 ofretaining member 120. The proximal portion of the prosthesis can includea plurality of self-expandable cells, arcs, or arches (generallyreferred to herein as cells), such as those features described inapplication Ser. No. 14/677,320, U.S. Pat. No. 8,870,948, andInternational Patent Application filed May 13, 2016 and titled“REPLACEMENT MITRAL VALVES.” The cells of the proximal portion of theprosthesis (e.g., the proximal anchor), when collapsed, interface withraised elements 125 such that they are looped around raised elements125. Raised elements 125 project radially outward, extending furtherradially than valleys 119, which are in between adjacent raised elements125 and whose configuration is defined by the configuration of theprojecting raised elements 125. The raised elements 125 are configuredand sized so that when sheath 116 is positioned over the raised elements125 (i.e., is disposed radially outwardly relative thereto), the spacebetween the inner surface of sheath 116 and the radially outermostsurface of raised elements 125 does not allow the cells of the proximalportion of the prosthesis to pass through the space. Raised elements 125and sheath 116 are therefore sized and configured to maintain theproximal-most portions of the prosthesis proximal to raised elements 125while the rest of the prosthesis is positioned distal to the raisedelements 125. This prevents the proximal portion of the prosthesis fromexpanding sooner than desired as the sheath is being retractedproximally during deployment of the prosthesis.

The sheath 116 and raised elements 125 are also sized and configured toallow the self-expandable proximal portion of the valve prosthesis toexpand radially outward only after the distal end of the sheath 116 hasbeen retracted far enough proximally relative to raised elements 125.Upon removal of sheath lock 153, sheath 116 can be retracted proximallyrelative to central control assembly to expose the prosthesis and allowfor self-expansion. That is, when the distal end of sheath 116 isretracted proximally past raised regions 125, the expandable proximalportion of the prosthesis will expand to its expanded configurationsince the radially constraint of the sheath has been removed.

FIGS. 2A-2B show a delivery device 200 that is configured to control theexpansion of the proximal portion of the anchor (as is the embodiment inFIG. 1 ) while allowing for recapture and/or movement of the proximalanchor was deployed. The delivery device 200 thus includes a centralstem 218, a proximally retractable sheath 216, and a central controlassembly. The central control assembly includes a plurality of loopedtethers 226 (see FIG. 2B) extending therethrough and an annular memberwith constraining elements 224 extending therearound.

The tethers 226 extend down the center of the device 100. The tethers226 form a loop at the distal end through which the constrainingelements 224 extend. In use, the looped tethers 226 can be extendedthrough portions of a prosthetic valve, such as the proximal anchor, andthen the ends of the tethers 226 can loop around the constrainingelements 224 (which are held in place by the sheath 216, as describedbelow). The tethers 226 can be configured to be loosened using controlsin the handle. When the loops of the tether 226 are loosed, the proximalend, of the prosthetic valve can expand, and when the loops aretightened, the proximal end of the prosthetic valve can collapse.Exemplary materials for the tethers 226 include polymers such as ForceFiber HDPE tether, a wire of nitinol, tungsten or stainless steel, or abraided tungsten or stainless steel cable.

The constraining elements 224 can be formed, for example, of a shapememory material and are configured to extend through the loops of tether226, as described above. In some embodiments, the constraining elements224 include a plurality of shape memory, e.g., nitinol, flaps or stripsthat are held down by the sheath 216, but open, release, or expand whenthe sheath 216 is retracted. The sheath 216 can thus retain theplurality of constraining elements 224 in closed or capturedconfigurations, thereby ensuring that the tethers remain looped throughthe valve.

FIGS. 2A and 2B show the sheath 216 extended fully distally over thestem 218. In this configuration, the valve prosthesis would be fullyenclosed within the sheath 216—with the distal portion of the valveprosthesis held in the collapsed configuration by the sheath 216 andwith the proximal portion of the valve prosthesis held in the collapsedconfiguration by the tightened tethers 226, which are in turn held inplace by the constraints 224.

FIGS. 2A-6 illustrate a sequence of using the device 200. Thus, FIG. 3shows the delivery device 200 after sheath 216 has been partiallyproximally withdrawn relative to the central stem 218 such that thedistal end of the sheath 216 is substantially aligned with the distalend of the annular member with constraining elements 224. In thisposition, the distal end of the prosthesis, e.g., the distal anchor,would be allowed to self-expand and/or deploy. However, because thedistal end of the sheath 216 is still distal to the capture elements224, the capture elements 224 are still in their closed configuration,thereby maintaining their hold on the tethers 226.

FIG. 4 shows the delivery device after tethers 226 are distally advancedby distally advancing the proximal most handle 109. Distally advancingthe looped tethers 226 loosens the loops relative to the prosthesis andallows the proximal portion of the prosthesis to be expanded. Tethers226, however, are still in position relative the proximal side to beable to collapse the proximal anchor if needed.

Thus, referring to FIG. 5 , the tethers 226 can advantageously be pulleddistally to tighten the tethers and collapsing the proximal anchor (e.g.for movement and/or optimal placement of the prosthesis). FIG. 5 thusshows the tethers 226 tightened, which would in turn recollapse theproximal portion of the prosthesis. If needed, the entire valve can beretrieved back inside sheath 216, where the delivery device looks likewhat is shown in FIG. 2 after sheath has been advanced distally.

Referring to FIG. 6 , to fully deploy and release the prosthesis (i.e.,after positioned properly with the tethers 226 still attached), thesheath 216 can be pulled distally past the constraining members 224,thereby causing the tethers 226 to pop out of the constraining members224.

FIG. 7 is another embodiment of a delivery device 300 that is similar tothe embodiment in FIGS. 2-6 . In this embodiment, however, captureelements 324 do not have shape memory configurations. In thisembodiment, capture elements 324 are configured to passively changeconfigurations from a closed or capture configuration to an open orrelease configuration. Each of the retaining elements 324 is configuredto mate with, or by keyed with, an indentation 325 of the centralassembly. In this embodiment, the capture elements 324 have asubstantially triangular shape. The mating configurations (with thesheath 316 thereover) keeps the capture elements 324 mated with theindentations 325. When sheath 316 is retracted past the capture elements324, the capture elements 324 will not automatically revert to an openconfiguration due to the material properties of the retaining elements324. Rather, they will be forced to an open configuration due to theself-expanding properties of the proximal portion of the prosthesis.Tethers, or other additional restraining elements can again be used tofurther control the expansion of the proximal portion of the prosthesis,as is described in the embodiment of FIGS. 2-6 .

FIG. 8 illustrates another delivery device 400. The delivery device 400includes a central stem 418 and a sheath 416, similar to as describedwith respect to other devices described herein. Further, captureelements 424 function similar to capture elements 324.

FIG. 9 illustrates an alternative delivery device 500 having a tetherends retainer 524 with pockets 531 therein configured to hold the endsof a tether (i.e., rather than having the tether loop around a captureelement). The details of such a tether ends retainer 524 be describedfurther below with respect, for example, to FIG. 11A. The tethers extendthrough tether lumens 532. In some embodiments, the ends of the tethers(or sutures, wires, or other controllable restraining elements) caninclude a radiopaque marker in a region configured to change positionwhen the proximal portion has been released from the restrainingelements. For example, the radiopaque marker can be in a region that isconfigured to “open.” By including a marker on the portion that isconfigured to change position when the proximal portion has beenreleased (and optional expanded), visualization can be used to determinewhen the proximal portion has been released by the restraining elementsand expanded.

FIG. 11A shows another embodiment of a prosthetic valve replacementdelivery device 700. The delivery device 700 includes a device proximalend 702 and a device distal end 704. As can be seen from FIG. 11Athrough 11C, the delivery device 700 has an elongated portion thatterminates at a nosecone 706 at the device distal end 704. The nosecone706 is coupled to a central stem 718, which is in turn coupled to atether ends retainer 720 (described in detail below). The elongatedportion includes an outer sheath 712 and an inner sheath 716. Thecentral stem 718 also couples to a series of tether/suture maintaininghypodermic tubes that are able to slide along the central stem 718 (thehypodermic tubes will be further described below). The inner sheath 716is configured to slide relative to the central stem 718 (extend andretract) to cover or expose certain retaining features of the deliverydevice, e.g., the tether ends retainer 720, (see FIG. 11B) as well asaid with maintaining the prosthetic valve within the delivery device 700prior to deployment. The device proximal end 702 includes a handle 709for holding onto the delivery device. Other components maintained withinthe proximal portion of the delivery device 700 will be discussed below.FIG. 11B shows a close-up of the distal end the delivery device 700,where it is more apparent that the nosecone 706 is attached to thecentral stem 718 and the central stem 718 is coupled to a tether endsretainer 720. FIG. 11C shows a cross-sectional view of the deliverydevice 700.

As best shown in FIG. 11B, the nosecone 706 is located at the devicedistal end 704 of the delivery device 700 and includes a tapered distaltip. The nosecone 706 is configured to aid with inserting the deliverydevice 700 into a position within a patient's heart for successful valveplacement. The nosecone 706 tip has a small surface area such that ifthe nosecone 706 touches any portion of the patient's heart, less damagewill be done to the heart. The nosecone 706 tip is also rounded or bluntso as to decrease the risk of puncturing the patient's heart if thenosecone tip contacts the surface of the heart.

Tethers 726 (see FIG. 20 ) aid with maintaining the prosthetic valvewithin the device 700. In most cases, the tethers are made of suturematerials. The proximal ends are maintained by the tether control lever738 while the distal ends are maintained within the tether retainer 720.The lengths of tether extend along and around the center stem 718, andeach thread through a separate tubular structure. The tether ends thatcouple to the tether retainer 720 further include a feature for couplingthe tether ends to the tether retainer 720, as is further discussedbelow.

The distal ends of the tethers are configured to loop through theproximal end, such as the prosthetic anchor, of the prosthetic valve.The distal ends of the tethers, once looped through the prostheticanchor, are maintained by the tether retainer 720. The tether retainer720 in relation to the delivery device 700, to the central stem 718 andthe nosecone 706, can be seen in FIG. 11B. FIG. 16 also shows the tetherretainer 720 unattached and by itself from two different angles. Thetether retainer 720 has a substantially annular or cylindrical shape andhas dimensions that allow it to fit within the inner sheath 716. Thetether retainer 720 includes a tether retainer center aperture 721 andan array of apertures 723 within its internal core. The tether retainercenter aperture 721 maintains the tether retainer 720 within thedelivery device 700. The tethers threaded through the array of apertures723, one tether per aperture. A series of hypotubes 732 (see FIG. 13C)are aligned with each of the apertures 723. Each single tether isthreaded through a hypotube 732 prior to exiting through the array ofapertures. The hypotubes 732 allows the individual tethers to be evenlyspaced about the delivery device 700 and prevents asymmetric arrangementof the tethers around the central stem 718. Symmetric loading ensuressymmetric tensioning of the proximal end petals of the prosthetic valve,improving the loading of the device and the release characteristics. Inthis embodiment, there are nine apertures and nine hypotubes thatmaintain individual tethers at an even spacing within the deliverydevice body. In other examples, there may be more or fewer apertures andhypotubes for maintaining individual or multiple tether lines.

Once all the tethers have been looped around the proximal end petals ofthe prosthetic valve, the free tether ends are brought back to thetether retainer 720. As can be seen from FIG. 16B, the outer surface ofthe tether retainer 720 includes a series of evenly spaced tetherpockets 724 that are in fluid connection with corresponding series oftether slots 722. FIG. 20A shows the delivery device 700 having freetether 726 ends. Each tether 726 distal end can include a truncatedcone, where an infinity knot at each tether end maintains the tetherwithin the corresponding truncated cone. The truncated cones can betapered distally to proximally. Each truncated cone may be inserted intoone of the pockets 724 and then each tether maintained within thecorresponding slot 722. The inner sheath 716 may be extended distally tocover the tether pockets 724. This aids with keeping the tether endswithin the tether pockets 724.

The truncated cones on the distal end of the tethers may be made of anysuitable rigid materials. The truncated cones are designed such thatthey easily release from the tether retainer 720. The geometry of thetruncated cone are configured specifically to fit the tether pockets724. The tether pockets 724 may also include additional features formaintaining the truncated cones of the tether ends when under tension.Further, the feature in the distal ends of the tethers need not beconical, but can be spherical or otherwise have a different shape.Materials for the distal features may include plastics, stainless steel,non-reactive polymers and so forth. In one example, the distal featuresare fabricated at least partially from tantalum.

The tether retainer 720 may also have a groove at its proximal end foran O-ring 708. The O-ring is to prevent excessive blood from penetratingrest of the delivery device during a procedure. Moreover, the distal endof the tether retainer 720 may have a diameter slightly less than thatof the proximal end. This allows the tether retainer 720 when fittedwith the O-ring to still fit within the inner sheath 716.

The tethers 726 are used to control the prosthetic valve within thedelivery device and aid with placement of the prosthetic valve at themitral valve site. The series of distal tether ends are maintainedwithin the tether retainer 720. Referring to FIG. 11A, the series ofproximal end tethers are held by tether (atrial) control lever 738. Thetether control lever 738 includes a series of apertures 739 for holdingthe proximal tether ends, where appropriate knots at the proximal tetherends hold the tethers in place. Alternatively, proximal tether ends mayinclude a knot holding feature that prevents the tether end fromslipping through the tether control lever 738. The tether control lever738 is a lever that allows the operator to easily adjust the tension onthe tether ends with their thumb. Once the tether ends have beenthreaded through the proximal end petals of the prosthetic valve andslotted into the tether pockets 724, the operator may tension the tetherby pulling back on the tether control lever 738 and pull the prostheticvalve into the inner sheath 716. After the tether ends have been loaded,the tether control lock 734 may be flipped down to contact a tethercontrol notch 736. The tether control lock 734 maintains the tethers inplace.

Once the replacement have has been loaded into the delivery device 700,tension is maintained on the tethers until the prosthetic valve has beenproperly positioned. The mechanism for maintaining tension on thetethers includes the thumb screw 752 and the tether control lever 738.FIG. 17 is a close-up of a cross section showing the secondary releaseknob 7140 and the tether control lever 738. A few of the hypotubes 732are visible. The proximal tether ends enter the tether control lever 738through tether control channels 739, and jog around a washer that isadjacent to secondary release knob 140 before it enters the hypotube 732jogs. A knot at the end of the proximal tether end prevents this endfrom slipping through the tether control lever 738. The secondaryrelease knob 740 when it is tightened against the washer adjacent to thetether control lever 738 maintains tension on the proximal tether endswhen the tether control lever 738 is pulled proximally.

Referring to FIGS. 12A-12C, the handle 709 of the delivery device 700includes the tether control lever 738. The tether control lever 738 iscoupled with a secondary tether release knob 740. The tether controllever 738 and the secondary tether release knob 740 work to maintain thesecond (proximal) ends of the tethers. Also coupled to the tethercontrol lever 738 on its distal side are the series of hypodermic tubes732 (hypotubes for short) that are disposed around the central stem 718.The series of hypotubes 732 each hold one tether and are able to extendand retract along with the tether control lever 738.

FIGS. 13A-13C show the delivery device 700 where the tether controllever 738 and secondary tether release knob 740 have been pusheddistally. This distal movement moves the series of hypotubes 732 as wellfrom a more proximal location to a more distal location along thecentral stem 718 such that the series of hypotubes 732 meet and abut thetether ends retainer 720. When doing so, the tether ends retainer 720remains stationary in its position on the central stem 718. Thehypotubes 732 aide with keeping the tethers separated when there isslack in the tether lines as they are moved forward during deployment orwhen the prosthetic valve is being loaded. Notes that the tether endsretainer 720 remains stationary in its position on the central stem 718.This places the prosthetic valve in an optimal location on the deliverydevice 700 for loading and deployment.

Referring to FIG. 12A The handle portion 709 also includes an innersheath control knob 752 which is coupled to a lead screw 750. These twocomponents work to extend or retract the inner sheath 716. Sitting onthe proximal side of the sheath control knob 752 is a clip 754 thatprevents the inner sheath 716 from retracting too proximally until theprosthetic valve is ready to fully deploy, at which time the clip 754may be pulled off.

In use, a prosthetic valve is first loaded into the device 700. FIG. 20Ashows the loading of an exemplary mitral valve prosthesis 790. Theprosthesis valve 790 generally has a cage-like appearance with a centeraperture 793. The prosthetic valve 790 includes a proximal end petals791 and distal end petals 792. In this embodiment, the mitral valveprosthesis includes two anchors having a series of cells with radiallyextending petals or loops. To load the prosthetic valve into thedelivery device 700, the central stem 718 and nosecone 706 are firstinserted through the center aperture 793 of the prosthetic valve. Next,individual lengths of tether 76 from a series of tethers originatingfrom the device proximal end 702 and disposed around the central stem718 portion, loop around each petal portion from the proximal end of theprosthetic valve (the end closer to the proximal end of the deliverydevice). While not all of the petals from the proximal end of theprosthetic valve need to be coupled to an individual tether, enoughpetals should be coupled to individual tethers such that when the seriesof tethers are pulled axially in the proximal direction, all the petalsof the proximal end of the prosthetic valve will uncurl equally andevenly, and close in around the central stem 718. Then the free ends ofthe tether 726 having the truncated cones may be slipped intocorresponding pockets 724 of the tether retainer 720.

After tensioning the tethers/sutures and pulling the proximal sidepetals of the prosthetic valve straight using the tether control lever738, the inner sheath 716 may be extended distally with the sheathcontrol knob 752 such that it begins to cover the straightened outproximal side petals of the prosthetic valve. Further retracting thetether retainer 720 will cause the tensioning forces to translate toother parts of the prosthetic valve. This additional tension is now ableto pull the distal side petals on the prosthetic valve towards the innersheath 716. Recall that, at this point, the proximal end petals arealready maintained within the inner sheath 716, so that further tensionon the proximal end of the prosthetic valve will now straighten out thedistal petals of the prosthetic valve. Once the distal end petals of theprosthetic valve are completely retained within the inner sheath 716,then the delivery device 700 is fully loaded. The inner sheath 716 maybe extended fully distally until it meets with nosecone 706. This can bedone by rotating a sheath control knob 752. Rotating the sheath controlknob 752 in one direction will extend the inner sheath 716 until itmeets up with the nosecone 706, while rotating the sheath control knob752 in the opposite direction will retract the inner sheath 716proximally along the elongated portion 701 of the delivery device 700.

In some embodiments, a tether loading cone 710 (see FIG. 11A) may beused to aid with loading a prosthetic valve into the delivery device700. The operator can apply tension to the series of tethers using thetether control lever 738 such that the prosthetic valve proximal petalsare straightened enough to fit into the inner sheath 716. The tetherloading cone 710 aids with directing the individual petals into innersheath 716. As the operator continues to pull the series of tethersproximally, the proximal end petals will be completely housed within theinner sheath 716 followed by the central portion of the prosthetic valve(FIG. 20C). Once the prosthetic valve central portion has been pulledinto the inner sheath 716, the tension being exerted on the prostheticvalve will continue to pull the prosthetic valve axially in the proximaldirection such that the distal end petals now begin to uncurl andstraighten out while being pulled into the inner sheath 716. Theprosthetic valve is now completely loaded when the entire valve ismaintained within the inner sheath 716 even though tension is stillbeing maintained on the proximal end of the prosthetic valve through thetether control lever 738. Once the prosthetic valve has been loaded, thetether loading cone 710 may be removed and the valve placement proceduremay proceed.

An outer sheath may be used to assist with delivery of the device 700.Thus, the delivery device 700 includes an outer sheath 712, which can beseen in FIGS. 12A-12C. FIG. 12A is a schematic of the delivery device700. FIG. 12B shows a cross-section of the delivery device 700 along alongitudinal plane and FIG. 12C shows a close-up of the cross-sectionfor the distal end of the delivery device 700. FIG. 12A shows the outersheath 712 relative to the inner sheath 716. The outer sheath 712 isprimarily used during insertion of the delivery device 700 into apatient's body cavity. The outer sheath 712 is slide-able along theelongated portion 701 to cover the elongated portion 701 up to thenosecone 706. Once an incision is made, a suture is purse stringstitched around the perimeter of the incision. This allows the incisionto be made smaller by pulling on the (purse string stitched) suture. Ascan be seen from FIG. 12A, the outer sheath 712 includes an outer sheathgroove 714 disposed around its distal end. The incision may be cincheddown around the outer sheath groove 714 such that the incision site isessentially closed off except for the delivery device 700. This isadvantageous because it minimizes exposing a patient's internal systemto the outside environment thereby reducing risk of harmful agentscoming into contact with a patient's internal system. In addition,having the incision site cinched around the delivery device 100 alsoreduced the amount of blood loss during the procedure.

Because the outer sheath 712 is configured to move axially with respectto the remainder of the delivery device 700, an operator will still beable to maneuver the delivery device 700 within the incision siteaxially and also to some extent in a circular fashion within theincision site for finding optimal position to deploy the prostheticvalve. Thus the outer sheath 712 remains stationary once the incisionsite sutures have been tightened around the outer sheath groove 714, andthe delivery device 700 is able to deliver the prosthetic valve with usecomponents of the delivery device that are further described below.

Using the sheath 712, the operator may position the device distal end704 in the proper location within the patient's heart. Once the operatoris satisfied with the location of the device distal end 704, the sheathcontrol knob 752 can be rotated to pull the sheath 716 proximally andexpose the distal end petals of the prosthetic valve. FIGS. 13A and 13Bshow the inner sheath 716 retracted, which would expose the distal endof the valve (allowing it to expand) and expose the collapsed proximalend of the valve (held in the collapsed configuration by the tethers).

To expand the proximal end of the valve, the tether control lock 734 isunlocked so that the operator may begin to adjust the tether controllever 738. By pushing the tether control lever 738, tension on thetethers are lessened. The reduced tension on the tethers in combinationwith the inner sheath 716 being retracted, allow the series of distalpetals on the prosthetic valve to curl back into their natural shape forpositioning. Advantageously, at this point, if the operator decides thatthe proximal anchor and/or the entire valve has not be positioned asdesired, the tethers can be tightened again, causing the proximal anchorto collapse. The inner sheath can then be advanced, fully covering thevalve and allowing it to be either repositioned or removed entirely.

Once the positioning of the valve is finalized, the operator can releasethe valve from the delivery device 700. Referring to FIG. 14 , to do so,the clip 754 disposed at the end of a lead screw 750 (shown in FIG. 12A)until now, has function to prevent the inner sheath 716 from retractingtoo far, may be removed. As shown in FIGS. 15A-15B, this allows thesheath control knob 752 to travel further toward the device proximal end702 for releasing the tether ends (FIG. 14 ). Specifically, the clip 754may be removed to allow the inner sheath 716 to retract to the farthestproximal position possible. Once at the inner sheath 716 is at thefarthest proximal position, the tether retaining pockets 724 becomeexposed, and without the inner sheath 716 to maintain the tether endswithin the pockets 724, the proximal tether ends are allowed to pop outof their respective pockets 724 and the proximal side of the prostheticvalve is able to deploy.

Now the entire prosthetic valve has been deployed and the deliverydevice may be removed. The outer sheath 712 can remain coupled to theincision site thought the outer sheath groove 714 and the purse-stringsuture. However, once the purse-string sutures are removed, then theentire delivery device may be removed.

In some embodiments, an operator may desired an alternative oradditional method for removing the tethers from the proximal anchor(e.g., if the tethers get caught in the anchor and/or don't pop out ofthe pockets).

Referring to FIGS. 11A and 17 , the secondary release knob 740 providesan alternative method of releasing the tethers if the tethers becometangled or fouled up during prosthetic valve loading or deployment. AsFIG. 17 shows, the tethers are threaded through the tether control lever738 past a washer or cushion before travelling distally to where thedistal ends will loop around the prosthetic valve. As can be seen inFIG. 17 , the secondary release knob 740 is screwed down against thewasher or cushion to maintain tension on the tethers. In instances wherethe operator needs to reload the tethers, the release knob 740 may beused. To use the release knob 740, the operator rotates the knob 740 inthe direction that reduces the force on the washer/cushion, therebyreleasing tension on the tether ends against a washer. Because there isno need to adjust the secondary release knob 740 unless the operatorneeds to adjust tangled or stuck tethers, the secondary release knob 740may be color coated a different color (i.e. red) to alert the operatorthat this knob should not be adjusted unless absolutely necessary toprevent the operator from inadvertently releasing the tether ends priorto fully loading the prosthetic valve or accidentally deploying theprosthetic valve prior to finding an optimal position for the valve.

An alternative embodiment of the alternative tether release mechanism isshown in FIGS. 18A and B. Here, a truncated cone 782 and correspondingfunnel-shaped washer 780 apply tension to the proximal tether ends. Thepath that the tether ends take in this configuration has a much morenatural angle compared to the approximately ninety degree angle jog thatthe proximal tether ends must take in the prior configuration described(FIG. 17 ). In this example, the tethers or sutures are threaded threeeach into each of the three channels 785. In this alternativeconfiguration, a thrust bearing 784 is used to prevent rotation of thewasher 780 when threading the thumb screw 750. In the absence of thisfeature, when the thumb screw 750 is rotated with a certain amount offorce on the tethers 726 and potentially twist the tethers 726 togetherwhich could lead to difficulty adjusting the tension on the tethers.

In some embodiments, the delivery device 700 also includes a grasper 760as shown in FIGS. 11A, 21A, and 21B. The grasper 760 allows the operatorto adjust the depth with which the device distal end 704 penetrates thepatient's heart chamber as well as aids with maintaining the deliverydevice 700 during use. In general, the grasper 760 includes a graspercoupling aperture 762, grasper magnets 764, and a grasper adjustmentknob 766 mechanically coupled to a grasper coupling wheel 768. Thegrasper 760 generally has an oblong shape. On one end, the grasper 760includes the grasper coupling aperture 762 and on the opposing end isthe grasper adjustment knob 766 coupled to the grasper coupling wheel768. On its bottom surface is the grasper magnet 764 adjacent to thegrasper coupling wheel 768. The grasper coupling wheel 768 is situatedin an opening where it is raised above the surface of the grasper. Ascan be seen from FIG. 22 , the delivery device 700 includes a devicemagnet strip 758 disposed on one side of the device. The device magnetstrip 758 may be a single rectangular magnet or a series of individualmagnets. In use, the grasper magnets 764 are able to couple to thedevice magnet strip 758. Adjacent to the device magnet strip 758 are aseries of device tracks 756. The device tracts 756 are able to couple tothe grasper coupling wheel 768 such that when the operator rotates thegrasper adjust knob 766, the teeth of the grasper coupling wheel 768 areable to travel proximally and distally along the device tracks 756. Thegrasper coupling aperture 762 in this current example is a threadedconnection that couples the grasper 760 to a standard VBM arm forsupporting and adjusting the delivery device 700. When the grasper 760is coupled to both the delivery device 700 and a support arm (such as aVBM arm), the operator may adjust the depth of the delivery devicedistal end 104 within the patient's heart cavity by simply adjusting thegrasper adjust knob 766.

In some embodiments, the delivery device 700 includes a ratchetingmechanism for preventing back-driving (e.g. slippage) of the tethercontrol lever 738 and the secondary release knob 740. A schematic of theratcheting mechanism is shown in FIG. 19 . FIG. 19 is a cross-section ofthe secondary release knob 740. The secondary release knob 740 includesa release knob central stem 745 and a release knob center screw 746contained within. The release knob central stem 745 includes internalfeatures for accommodating the natural outer profile of the turns of therelease knob center screw 746. The release knob center screw 746includes a series of ratcheting teeth 770 at its proximal and distal endwithin the release knob central stem 745. Disposed on two sides of therelease knob central stem 745 are a series of three indentations 772 oneach of the sides. The secondary release knob 740 includes two channels771 situated on opposite sides of each other (180 degrees apart). Withineach channel 771 closest to the release knob central stem 745 areidentical ball bearings 774. Adjacent to each of the ball bearings 774are two identical springs 776 and adjacent to the springs on theiropposite side are two ratchet actuators 778. The ratcheting mechanismhas three possible positions based on which well of the series ofindentations 772 the ball bearing 774 is seated. When the ball bearing774 is in the most proximal well, this places the ratchet mechanism in aposition that prevents back-driving of the secondary release knob 740and the tether control lever 738. When the ball bearing 774 is in themost distal well, this places the ratchet mechanism in a position thatpreviews forward driving of the secondary release knob 740 and thetether control lever 738. Finally, when the ball bearing 774 is in thecenter position within the series of indentations 772, the secondaryrelease knob 740 and the tether control lever 738 are free to moveeither distally or proximally along the axis of the release knob centerscrew 746. In some examples, the operator will pull the actuators 778 torelease tension against the ball bearing 774 and adjust the tethercontrol knob 738 to move the ball bearing 776 between the three possiblepositions. In other examples, the ratchet actuators 778 has twopositions. In a first position, the ratchet actuators 778 maintains aforce against each ball bearing 774 through the springs 776 to keep ballbearing 776 within the desired indentation 772. In a second position,the operator is able to release the force the ratchet actuator 778exerts upon the ball bearing 774 and by adjusting the secondary releaseknob 740, is able to transfer the ball bearing 774 into a different wellwithin the series of indentations 772.

In any of the embodiments herein, the proximal portion of the prosthesismay be expanded before the distal portion. For example, if it isdifficult to advance the delivery device far enough into a leftventricle to deploy the distal portion first, or if it is undesirable todeploy the distal portion first against mitral valve anatomicalstructures (e.g., the chords), the proximal portion can be deployedfirst. The delivery devices herein can be modified with an outercomponent that can be axially moved to allow the proximal portion toexpand while still radially constraining the distal portion forsubsequent expansion.

Turning to FIGS. 23A-G, another embodiment of the mitral valvereplacement delivery device 800, is shown. The delivery device 800shares many of the same features as the delivery devices alreadydescribed, and thus, features that function the same will not beredundantly described, unless required for clarity. The major differencebetween the delivery devices already described and the delivery device800 is that the previously described delivery devices, the distal endpetals of the prosthetic valve are deployed first followed by theproximal end petals, while for the delivery device 800, the proximal endpetals are deployed first. The delivery device 800 has a device proximalend 802 and a device distal end 804. The delivery device 800 includestwo inner sheaths, a distal inner sheath 815 and a proximal inner sheath816. The distal inner sheath 815 is able to telescope over the distalend of the proximal inner sheath 816 (FIGS. 23A and B). FIGS. 23 C and Dshow how the proximal inner sheath 816 may be extended and retracted inconjunction with the distal inner sheath 815. Similar to the previousdelivery devices, the delivery device 800 includes a tether retainer820, where the tether retainer 820 is stationary along the centrals stem818. The prosthetic valve is held in the same manner and orientation asin the previous delivery devices.

Once the prosthetic valve has been coupled to the tethers and the tetherends maintained with the tether retainer 820, the tether control lever838 may be pulled proximally to tension the proximal petals of theprosthetic valve to close the petals about a central stem 818. Thedistal end petals of the prosthetic valve may then be forced into aclosed position by further pushing the proximal distal sheath 816distally so that it eventually covers the entire prosthetic valve. Oncethe entire prosthetic valve has been collapsed, the distal inner sheath815 may cover a portion of the proximal inner sheath 816. The distalinner sheath 815 is controlled by a distal inner sheath controller 819,which is able to retract and extend the distal inner sheath 815. At itsmost distal position, the distal inner sheath 815 abuts the nosecone806. Once the collapsed prosthetic valve is within the distal innersheath, the proximal inner sheath 816 may be retracted proximally.

To release the prosthetic valve, tension on the tethers may be relaxed.As FIGS. 23E and F show, the distal and proximal inner sheaths 815 and816 may be positioned to expose the proximal end petals of theprosthetic valve first. This is done by pulling the proximal innersheath 816 slightly in the proximal direction while also extending thedistal inner sheath 815 in the distal direction to first expose theproximal petals. Once the proximal end petals of the prosthetic valveare fully open and positioned, the operator may move the distal innersheath 815 distally to expose the distal end petals of the prostheticvalve, where the distal petals will naturally curl/flair out to theirnatural state once the constriction by the distal inner sheath 815 hasbeen removed. The proximal inner sheath 816 may be further retracted toexpose the tether retainer 820 so that the tether pockets containing thetether ends are exposed and the tether distal ends may pop from eachrespective pocket. The delivery device 800 may also include an outersheath for initially positioning the device within the patient's heart.

Yet another embodiment for prosthetic valve delivery, a delivery device900, can be seen in FIG. 24A-24F. The delivery device 900 also releasethe proximal end petals of the prosthetic valve first. The deliverydevice 900 as shown in FIG. 24A uses a slightly different mode ofmaintaining the tether for the prosthetic valve compared to deliverydevice 800. Similar to delivery device 800, the delivery device 900includes a shorter distal sheath 915 that abuts a nosecone 906 at adevice distal end 904. The delivery device 900 includes a distal sheath915 that may extend and retract with the use of a sheath controller 952(FIG. 24B). The delivery device 900 further includes a central stem 918.Unlike in previous configurations, the central stem 918 here furtherincludes a series of nesting tubes. In this particular configuration,nine nesting tubes 933 are arranged around a center core that runs tothe nosecone 906. The center core houses a guidewire known in thecatheter arts. Instead of a tether control lever, the delivery device900 includes a tether control knob 938, where the tether control knob938 functions to increase, decrease, or maintain tension on the tetherends. Similar to the other delivery devices, the proximal ends of thetethers are maintained at the tether control knob 938. In one example,each tether runs from the tether control knob 938 to a nesting tube 933until it reaches the tether retainer 920. Each tether exits itsrespective nesting tube at a distal location and threads into acorresponding tether retaining aperture 923, where each tether travelsthe length of the tether retainer 920 and exits the tether retainingapertures 923 at its proximal end. From there, each tether distal endmay be introduced into corresponding tether pockets 924 and tether slots922.

To load a prosthetic valve, the free tether ends near the distal end ofthe delivery device 900 are looped around the distal end petals of theprosthetic valve. Once the tethers have been coupled to the prostheticvalve, the tether control knob 938 may place tension on the distal endpetals through adjusting the tether control knob 934 and pull them closetoward the central stem 918. In delivery device 900, the distal sheath915 may be pulled back proximally along a central stem 918. When thedistal end petals have been so tensioned as to pull them straight, thedistal end sheath 915 may be extended proximally to cover the distal endpetals. Further retracting the distal end sheath 915 will begin to coverthe proximal end petals of the prosthetic device. The collapsedprosthetic valve and the tether retainer 920 are eventually completelymaintained within distal inner sheath 915. The sheath control knob 952adjusts the position of the distal inner sheath 915 through lead screw950. The distal sheath 915 abut the nosecone 906.

For deploying the prosthetic valve, the distal inner sheath 915 may beextended distally relative to the tether retainer 920 by adjusting thesheath control knob 952. When this occurs, the proximal end petals areexposed. Because the distal inner sheath 915 was the only thing keepingthe proximal petals in a straightened configuration, once thisconfinement is removed, the proximal end petals will relax and curl totheir natural shape (FIG. 24C). Once the proximal end petals have beenplace in an optimal location within the patient's heart, the distalinner sheath 915 may be further extended distally in conjunction withrelaxing tension on the tether ends through adjusting the tether controlknob 938 which allow the distal end petals to relax and expand (FIG.24D). The distal inner sheath 915 may be further advanced distally suchthat the pockets of the tether retainer 920 are exposed and the tetherends are allowed to become uncoupled to the tether retainer 920 (FIG.24E). Finally the tether ends may be tensioned so that they are pulledfree from the prosthetic device completely (FIG. 24F), where now thedelivery device may be removed.

FIG. 10 shows another exemplary delivery device 600 that is configuredto expand the proximal portion before the distal portion. The centralassembly of delivery device includes an expansion control member, and inother embodiments herein. However, in this example, the expansioncontrol member is positioned and configured to maintain the distalportion in a collapsed configuration. The proximal portion is allowed tofreely expand upon retraction of the outer sheath. In use, the sheathcontrol handle 652 is retracted in the proximal direction (as shown bythe arrow), causing proximal sheath 616 to be withdrawn proximally. Thiscauses the proximal portion of the expandable anchor to self-expand. Thedistal portion of the expandable anchor is still maintained in acollapsed delivery configuration radially within the distal sheath 615.To expand the distal portion of the anchor, sheath control handle 652 isadvanced distally, causing distal sheath 615 to be distally advanced (asshown by the arrow) past the distal portion of the expandable anchor.This causes the distal anchor portion to self-expand. Thus, device 600is configured such that a proximal portion of the expandable anchor isexpanded before the distal portion.

The device in FIG. 10 can similarly include any of the additionalrestraining elements (e.g., tethers) described herein to further controlthe expansion of either the proximal or distal anchor portions.

In all the embodiments that allow for deployment of the proximal endpetals of the prosthetic valve, an outer sheath may be present formaintaining the incision site similar to what was described for thedelivery device that provided deployment of the prosthetic valve distalend petals first.

For any of the delivery devices described herein, certain portions ofthe delivery device may be composed of transparent or see-throughmaterial. This may aid the operator with visualizing what is occurringto the tether lengths and/or prosthetic valve while held within theinner and/or outer sheath.

One or more tethers or suture loops may or may not be included in any ofthe embodiments herein. For example, any of the restraining elementsherein may be used in system that utilizes tethers, but they may also beused in devices without tethers (or tethers).

Aspects of the delivery devices and methods may be combined with aspectsof the delivery devices and methods described in U.S. patent applicationSer. No. 14/677,320, U.S. Pat. No. 8,870,948, or International PatentApplication filed May 13, 2016 and titled “REPLACEMENT MITRAL VALVES,”the entirety of which is incorporated by reference herein.

Although described herein for use with a mitral valve prosthetic, thedelivery systems described herein can be used with a variety ofdifferent implantable devices, including stents or other valveprosthetics.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising” means various components can be co-jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

What is claimed is:
 1. A method of delivering a prosthetic mitral valveinto a patient, comprising: extending a delivery device into a heartwith the prosthetic mitral valve collapsed within a sheath of thedelivery device; pulling the sheath proximally to expose at least adistal anchor of the prosthetic mitral valve, thereby enabling thedistal anchor to self-expand to an expanded annular configuration on afirst side of the mitral valve annulus; pulling the prosthetic mitralvalve proximally to seat the distal anchor in the expanded annularconfiguration against the mitral valve annulus; loosening a plurality oftethers of the delivery device so as to enable a proximal anchor of theprosthetic mitral valve to self-expand to an expanded annularconfiguration on a second side of the mitral valve annulus; pulling thesheath further proximally to withdraw the tethers from the proximalanchor; and removing the delivery device from the heart.
 2. The methodof claim 1, wherein the step of pulling the sheath further proximallyreleases distal ends of the tethers.
 3. The method of claim 1, furthercomprising releasing a proximal end of at least one of the tethers if adistal end of the at least one tether becomes tangled.
 4. The method ofclaim 1, wherein distal ends of the tethers are positioned withinpockets of the delivery device, and the step of pulling the sheathfurther proximally releases the distal ends of the tethers from thepockets.
 5. The method of claim 4, wherein the distal ends of thetethers include enlarged features configured to fit within the pockets.6. The method of claim 5, wherein the enlarged features are cones orspheres.
 7. The method of claim 1, wherein the expansion of the proximalanchor causes the proximal anchor to move towards the distal anchor andto capture tissue of the mitral valve annulus between the proximalanchor and the distal anchor.
 8. The method of claim 1, furthercomprising, prior to the step of pulling the sheath further proximally:tightening the plurality of tethers to re-collapse the proximal anchor;moving the distal anchor to a new position against the mitral valveannulus; and re-loosening the plurality of tethers so as to enable theproximal anchor to self-expand to the expanded annular configuration onthe second side of the mitral valve annulus, the expansion of theproximal anchor causing the proximal anchor to move towards the distalanchor and to capture tissue of the mitral valve annulus between theproximal anchor and the distal anchor.
 9. The method of claim 1, whereinprior to loosening the plurality of tethers of the delivery device, theplurality of tethers are looped around the proximal anchor.